NCT03839732: CALCIFY2D

Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry

Completed Last updated 24 May 2023

What this trial tests

trial testing Score of abdominal aorta calcifications in Vascular Calcification in 44 participants. Completed in 27 April 2021.

Timeline

28 November 2018

Primary endpoint
31 October 2019

27 April 2021

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Status	Completed
Study type	OBSERVATIONAL
Enrollment	44
Start date	28 November 2018
Primary completion	31 October 2019
Estimated completion	27 April 2021
Sites	1 location across Italy

Drugs / interventions tested

• Score of abdominal aorta calcifications

Conditions studied

• Vascular Calcification — all drugs for Vascular Calcification →
• Vertebral Fracture — all drugs for Vertebral Fracture →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

20 and older, any sex, with Vascular Calcification or Vertebral Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BACKGROUND In the context of a progressively aging population, monitoring the status of Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events (hospitalization and/or death) and hip fractures respectively, and VF represent an under-diagnosed cause of progressive disability and pain on its own. Moreover, there is an acknowledged relationships between VC and VF.

However, data about the emergence/progression of VC and the emergence/worsening of VF over time are lacking. This is likely due to the absence of monitoring instruments for VC and VF that are both precise and easily accessible/applicable.

OBJECTIVE This study aims to define the observer variability of a new software developed by the study sponsor and collaborators, called Calcify2D. Calcify2D offers physicians a computer-assisted procedure to simultaneously score vascular calcifications at the abdominal aorta and lumbar vertebral fractures (according to Quantitative Vertebral Morphometry principles) based on a latero-lateral thoracolumbar spine radiography. Secondary aims are the validation of the scores obtained from latero-lateral thoracolumbar spine radiography with more invasive and/or costly gold-standard imaging modalities (Computed Tomography for VC, Magnetic Resonance for VF) that may have been acquired near-simultaneously to radiographs on the patients enrolled for the study.

STUDY DESIGN Not-for-profit monocentric observational study to be conducted on the diagnostic images of the thoracolumbar spine already collected at Istituto Ortopedico Rizzoli (IOR) within a previous interventional study.

Scoring of VC and VF will be performed by four clinicians from four relevant specialties, chosen among those who may often see VC and VF and are already familiar with the traditional scoring systems for both VC and VF (one radiologist and one spine orthopaedics from IOR, one nephrologist from the National Research Council and one internist from University of Padua).

Each clinician will assess all radiographs to score VC and QVM, both via computer assisted procedures and via traditional visual inspection. To avoid bias, an interval of at least one week will be left between the computer assisted and visual scoring. To define intra-observer variability (i.e. repeatability), the whole dataset will be re-assessed three times.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Novel Quantitative Computer-Assisted Score Can Improve Repeatability in the Estimate of Vascular Calcifications at the Abdominal Aorta.
   Fusaro M, Schileo E, Crimi G, Aghi A, et al · · 2022 · cited 12× · PMID 36296959 · DOI 10.3390/nu14204276